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FDA Approvals - FDA Approves Advair 250/50 For Reduction Of Exacerbations In Patients


FDA Approves Advair 250/50 For Reduction Of Exacerbations In Patients With COPD (Medical News Today)
The U.S. Food and Drug Administration approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. With this approval, Advair becomes the only treatment FDA has approved to reduce COPD exacerbations.

FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem's Regulatory Submissions in Support of a Phase I/II ... (Business Wire via Yahoo! Finance)
NEW YORK----Pluristem Therapeutics Inc. , a bio-therapeutics company dedicated to the commercialization of non-personalized cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that the Paul Ehrlich Institute in Germany has approved the pre-clinical study synopsis to support a Phase I/II clinical trials in Germany and that the Center for ...

FDA Sends Warning Letter To Merck About Manufacturing Problems At Pa. Plant (Medical News Today)
FDA on April 28 sent a warning letter to Merck officials informing them that agency investigators discovered manufacturing deficiencies at the company's vaccine plant in West Point, Pa., the Wall Street Journal reports. The vaccines produced there include Gardasil, the cervical cancer vaccine, as well as certain childhood vaccines (Loftus, Wall Street Journal, 5/1).
 

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